SimplyGo MiniRecalls & reported problems across all models
Respironics, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SimplyGo Mini model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 134
- Deaths reported
- 9
- Injuries reported
- 12
- Recalls
- 1
We found 11 models of SimplyGo Mini by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Jun 2, 2026 — classified as 9 deaths, 12 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (25 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SimplyGo Mini recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 7, 2025Open, Classified
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Z-0481-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported SimplyGo Mini problems
Device problems
- Overheating of Device25
- Thermal Decomposition of Device21
- Noise, Audible15
- Adverse Event Without Identified Device or Use Problem11
- Crack8
- Power Problem7
- Contamination6
- Insufficient Device Problem Information6
Patient problems
- No Clinical Signs, Symptoms or Conditions113
- Insufficient Information8
- Low Oxygen Saturation4
- Inflammation2
- Unspecified Respiratory Problem2
- Vomiting2
- Cardiac Arrest1
- Dizziness1
SimplyGo Mini models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SimplyGo Mini SimplyGo Mini, USGenerator, oxygen, portable1 recall1 death5 reports
- SimplyGo Mini SimplyGo Mini with Standard Battery, USGenerator, oxygen, portable7 deaths37 reports
- SimplyGo Mini SimplyGo Mini with Extended Battery, USGenerator, oxygen, portable30 reports
- SimplyGo Mini SimplyGo Mini with Extended Battery, INTLGenerator, oxygen, portable26 reports
- SimplyGo Mini SimplyGo Mini with Standard Battery, INTLGenerator, oxygen, portable1 death12 reports
- SimplyGo Mini SimplyGo Mini, Standard Battery, JPGenerator, oxygen, portable8 reports
- SimplyGo Mini SimplyGo Mini with Standard Battery, IKKGenerator, oxygen, portable6 reports
- SimplyGo Mini SimplyGo Mini, INTLGenerator, oxygen, portable4 reports
- SimplyGo Mini SimplyGo Mini with Extended Battery, IKKGenerator, oxygen, portable4 reports
- SimplyGo Mini SimplyGo Mini, JPGenerator, oxygen, portable1 report
- SimplyGo Mini SimplyGo Mini with Extended Battery, ITGenerator, oxygen, portable1 report
Recent SimplyGo Mini adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Excessive Heating
THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNED PCA. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368935 ↗MalfunctionMay 27, 2026Overheating of Device
A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE PCA WAS BURNED AND REQUIRED REPLACEMENT. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301050 ↗MalfunctionApr 30, 2026Overheating of Device
A SIMPLYGO MINI DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED A THERMAL EVENT WITH BURN MARKS AND BURNT PCA. THE DEVICE WILL BE RETURNED TO THE PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049942 ↗DeathApr 29, 2026Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A SIMPLYGO MINI HAS PASSED AWAY. IT IS ALLEGED THAT THE CAUSE OF DEATH WAS CARDIAC ARREST FROM USING THE DEVICE. THE REPORTED EVENT MAKES NO ALLEGATION OF MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS WAS NOTED REGARDING THE DEVICE DURING THE TIME OF THE PATIENT USE, USER ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.
Patient problems: Cardiac Arrest
MAUDE report 25027140 ↗MalfunctionMar 20, 2026Sparking
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO MINI DEVICE. THERE WAS AN ALLEGATION OF CHARGING CONNECTOR HAD DETERIORATED, AND THE CABLE HAD BROKEN NEAR THE CONNECTION POINT. THE CABLE WAS REPLACED WITH A NEW ONE. WHEN IT WAS CONNECTED TO AN OUTLET IN THE OFFICE AS A TEST, A SPARKING SOUND WAS OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER INVESTIGATION IS ONGOING. A FOLLOW REPORT WILL BE SUBMITTED WHEN MANUFACTURER INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653949 ↗MalfunctionMar 11, 2026Sparking
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A SIMPLYGO MINI DEVICE. THE PATIENT STATED HER DEVICE DOES NOT SEEM TO BE CHARGING, JUST TRIED PLUG THE DEVICE IN AND IT SPARKED. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570979 ↗DeathMar 3, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH SIMPLY GO MINI HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 24502981 ↗MalfunctionFeb 12, 2026Smoking
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLY GO MINI DEVICE WITH AN ALLEGATION USING A CAR CIGARETTE LIGHTER SOCKET, SMOKE CAME OUT OF THE SOCKET (ON THE CAR SIDE) MACHINE. THE DEVICE TURNS OFF BUT THE STANDBY SYMBOL REMAINS DISPLAYED. THE PATIENT PULLED IT OUT OF THE SOCKET, SO NOTHING HAPPENED. AT THE SITE, THE CABLE AND EQUIPMENT OF THE SEGA SOCKET WERE NOT TURNED OFF. SINCE THE CONDITION WAS POOR, THEY DECIDED TO REPLACE IT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321516 ↗MalfunctionFeb 3, 2026Thermal Decomposition of Device
A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE SERVICE OBSERVED THE LOW O2 LEVELS WERE LOW BECAUSE THE MOLECULAR SIEVES WERE CLOGGED. ADDITIONALLY, LEAKS WERE IDENTIFIED ON BOTH THE OXYGEN AND A CIRCUITS. THE COMPRESSOR IS NOT OPERATING WITHIN NORMAL PARAMETERS, AND ITS TUBING IS CONTAMINATED. FURTHERMORE, THE PCA FAILED T START BECAUSE IT IS BURNT OUT, AND THE PATIENT FILTER IS CONTAMINATED. THE DEVICE RETURNED UNREPAIRED. FURTHER THE DEVICE WAS SENT TO PIL FOR FURTHER INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250771 ↗MalfunctionDec 22, 2025Overheating of Device; Overheating of Device
A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE A BURNED PCA BOARD. ADDITIONALLY, THE SIEVES WERE CLOGGED AND REQUIRED REPLACEMENT. BOTH THE AIR SIDE AND OXYGEN SIDE WERE CRACKED AND NEEDED REPLACEMENT, AND THE INLET FILTER REQUIRED REPLACEMENT AS PART OF PREVENTIVE MAINTENANCE. THE THIRD-PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LABORATORY FOR FURTHER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871288 ↗MalfunctionDec 18, 2025Smoking; Smoking
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO SIMPLYGO MINI DEVICE. THERE WAS AN INITIAL ALLEGATION OF SMOKE COMING OUT FROM THE DEVICE. ADDITIONALLY, BATTERY POWER BEING LOW AND VERY LOUD NOISE KNOCKING AT LEVEL 5. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843658 ↗MalfunctionDec 8, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SIMPLYGO MINI DEVICE WOULD NOT CHARGE. THERE WAS NO DEATH, SERIOUS HARM OR INJURY WERE REPORTED, AND NO MEDICAL INTERVENTION WAS PROVIDED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND THAT THE DEVICE HAD A BURNT PCA (PRINTED CIRCUIT ASSEMBLY). DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23750817 ↗MalfunctionDec 3, 2025Overheating of Device; Overheating of Device
THE SIMPLYGO MINI WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION WITHOUT AN INITIAL CUSTOMER COMPLAINT. DURING THE EVALUATION IT WAS NOTED THAT THE MAIN PRINTED CIRCUIT ASSEMBLY HAD THERMAL DAMAGE. ADDITIONALLY, A TECH FAULT WAS REPORTED, THE REAR COVER WAS FOUND CRACKED, THE O2 SIDE ASSEMBLY AND AIRSIDE ASSEMBLY WERE FOUND CONTAMINATED THEREFORE THEY WERE REPLACED. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709293 ↗MalfunctionNov 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN INITIAL ALLEGATION OF WON¿T TURN ON. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS INSPECTED, AND THE TECHNICIAN NOTICED THAT THE PCA IS BURNT. ADDITIONALLY, THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS. THE DEVICE WILL BE RETURNED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591745 ↗MalfunctionNov 17, 2025Sparking; Sparking
THE MANUFACTURER RECEIVED INFORMATION ON A SIMPLYGO MINI DEVICE ALLEGING "SPARKS BETWEEN THE DEVICE AND SOCKET." THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577808 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- Trilogy46 models · 21,644 reports · 11 recalls
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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